The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- benzodiazepine withdrawal severity
研究概览
简要总结
The aim of this study is to determine whether valproate is effective in the treatment of benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate dependence.
详细描述
In Finland, 90% of subjects with opioid dependence are dependent on benzodiazepines too. Concurrent use of opioids and benzodiazepines has increasingly caused deaths.
Benzodiazepine withdrawal treatment usually comprises gradual drug discontinuation. In one study, valproate was shown to improve benzodiazepine discontinuation success in chronic benzodiazepine users. In the present study, the effectiveness of gradual benzodiazepine discontinuation combined with valproate treatment and carried out in an inpatient setting is compared with gradual discontinuation without pharmacological augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of benzodiazepine dependence (DSM IV-R)
- •Induction of buprenorphine or methadon maintenance treatment, or need of benzodiazepine withdrawal treatment during ongoing buprenorphine/methadon maintenance
排除标准
- •Pregnancy
- •History of convulsions
- •Unstable somatic diseases
研究组 & 干预措施
B
Gradual benzodiazepine discontinuation and valproate treatment
干预措施: valproate (Drug)
结局指标
主要结局
benzodiazepine withdrawal severity
时间窗: 3 weeks
次要结局
- benzodiazepine use(4 weeks after treatment)
- attrition from treatment(3 weeks)